Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Anxiety Disorders

Breast Neoplasms

Mental Disorders

Psychotic Disorders

Patients receive the current standard of care and are asked to answer the questionnaires mentioned below.

Patients receive the current standard of care and are asked to answer the questionnaires mentioned below.

Additionally, delivery of a take-home brochure to the patients during the first visit is planned. The biopsy is explained to the patient and performed by a psychological trained physician. Patient care by a psychologically trained physician is performed in the sense that patients are informed about their biopsy result by a specifically trained physician.

Patients do not receive any interventions but are treated according to current standard of care.

no intervention

Content of brochure is dealing with symptoms, as well as mammographic and ultrasound findings, which need further investigation, will be addressed. The procedure of the breast biopsy itself will be explained in detail. The time in which the histological diagnosis can be expected will be indicated and follow up in case of a benign histology and the necessary therapy in case of breast cancer will be addressed.

delivery of a take-home brochure

The physicians who perform the biopsies will be instructed by means of a psychological training how to give structured and standardized information in order not only to inform comprehensively, but also to meet the patients' emotional needs.

patient care by a psychologically trained physician

Rosanna Zanetti, PD Dr. MD

The project investigates prospectively whether anxiety in the context of breast biopsy can be reduced by the planed intervention (take-home brochure and structured and standardized information given by a psychologically trained physician who performs the biopsy).

The fact having to have a breast biopsy taken due to suspected breast cancer is an emotionally exceptional situation not only because of the threat to be diagnosed of cancer but also because the breast is perceived as a symbol of womanhood, sexuality and motherhood.

Time, however, is scarce in a busy outpatient setting. Nevertheless doctors and nurses at the outpatient breast clinic University Hospital Basel are empathetic and try to address anxiety and give emotional support before, during, and after a necessary breast biopsy. Study findings, however suggest, that the level of anxiety, pain and discomfort associated with breast biopsies is considerable, which might not be sufficiently controlled by empathy alone but might be reduced by giving structured and standardized information.

The investigators hypothesize that the planned intervention reduces the level of anxiety in patients going for breast biopsy and thus is superior to the current standard of diagnostic procedures.

The project focuses on improving the patients' knowledge about the procedure of breast biopsy and on meeting their emotional needs to reduce anxiety related to the biopsy by giving structured and standardized information. Additionally the project investigates whether patients diagnosed with breast cancer have a higher level of anxiety than patients with benign breast disease. Furthermore the study assesses how precisely the physicians, who perform the biopsy, appraise the patients' perception of anxiety, pain and satisfaction related to the breast biopsy.

The primary objective is to demonstrate that the intervention reduces the patients' anxiety compared to the standard of care.

The intervention consists of (1) handing out a take-home brochure to the patient as well as (2) providing structured standardized information about the biopsy by the physician who performs the biopsy and who underwent psychological training for this purpose.

Secondary objectives are:

Does the intervention reduce anxiety during and after biopsy? Is there a correlation of the level of anxiety and the histological diagnosis of breast cancer? Does the waiting time between the procedure and the histological diagnosis have any influence on the level of anxiety? How is the patient's perception of pain during and after the biopsy? Is there a correlation between the patient's perception of pain and anxiety and the physicians' impression of the patient's perception? Is the patient satisfied with the additional take-home brochure and / or the structured and standardized information giving? This is a prospective study to evaluate anxiety before and after the implementation of a structured intervention to reduce anxiety related to breast biopsy.

Eligible are women who speak and understand German and will need a skin biopsy, core biopsy or a vacuum assisted biopsy.

Women receiving a fine needle aspiration, examination of a pathologic nipple secretion, and abscess evacuation will be excluded.

Women who do not understand or do not speak the German language will be excluded.

Demographics and relevant baseline variables will be summarized for both groups of patients. Categorical data will be presented as frequencies and percentages. For continuous variables, the lower and upper quartile as well as the median will be presented. Baseline characteristics of the two groups will be compared using the proportion test for categorical variables and the Welch two-sample t-test for continuous variables.

Anxiety of patients will be measured at four points in time with State-Trait Anxiety Inventory (STAI): before and after biopsy as well as before and after the communication of the diagnosis. The difference in STAI score between patients receiving standard of care and patients with intervention will be compared using Wilcoxon's rank sum test (Mann-Whitney test) at a significance level of α = 0.05. The results of the questionnaires will be reported as estimates together with the 95% confidence interval. Secondary objectives will be assessed using non-parametric tests if appropriate.

Sample size was estimated to be able to detect a significant difference in anxiety measured by the State-Trait Anxiety Inventory (STAI) score (Spielberger, Consulting Psychologists Press (CPP) 1983) between the group receiving standard of care and the intervention group. In a recent study, Flory et al. (Flory and Lang) reported a mean STAI score of 48 points for breast biopsy patients which were used here to simulate data for the control group. By assuming an effect size of 5 score points, a mean score of 43 points was used for the patients with intervention. The scores of both groups were assumed to be normally distributed with a standard deviation of 11.9.

Sample size was calculated with a semi-parametric resampling method. Each sample size ni, was evaluated by simulating R=999 times ni individual patients from the above distributions. The scores of the two groups were compared using Wilcoxon's signed-rank test at a significance level of α = 0.05. Sample size was set to ensure at least a power, 1 - β, of 0.9.

For this study, totally 334 patients should be recruited to ensure 250 evaluable patients considering a drop-out rate of 25 %.

Empathy and Standard Diagnostic Procedures in an Outpatient Breast Clinic Might Not be Enough

University Hospital, Basel, Switzerland

60-minute once or twice a week for 6 months of Initial Remote Psychological Support Course .

Participants in control group will receive usual course.

Psychological support

Yun Hsiang Lee, PhD

Yun Hsiang Lee, Phd

When the patient's mood has not yet reached a moderate to high severity level, psychological support is usually provided by the clinical nurses. However, the result of past research showed that the needs of patients and their caregivers were not satisfied with the psychological level. Scholars pointed out that it may be related to factors such as excessive clinical workload or insufficient psychological support and care capacity. In addition, under the influence of COVID-19 in the past two years, medical staff are facing more physical and mental pressure. Oncology nurses have a heavy workload and are affected by the COVID 19 epidemic, which reflects that nurses need psychological support. Therefore, this study intends to reduce stress through remote physical and mental support activities, and use the Internet to intervene in guided relaxation and meditation. Considering the scheduling of clinical nurses, a remote and unstructured course content that does not require continuity will be selected, and then advanced to provide the empathetic care skills of oncology nurses.

The Effects of Multi-Psycho-Oncology Care Courses

The Effects of Multi-Psycho-Oncology Care Courses Through Remote Psychological Support, Emotional Awareness Situation Videos and Empathic Concern Intervention on Physical and Psychological Status, Self-Efficacy and Empathy in Oncology Nurses

Oncology nurses' physical and psychological state were measured by physical and psychological state survey. It use Numerical Rating Scale(VRS) 0-10. It is a 11 Point Likert Scale (e. g. 0 is no pain; 10 is unbearable pain).

Oncology nurses' self-efficacy were measured by self efficacy scale. There are 10 questions about the level of confidence in these situations. It's a 4 point (1-4),higher the score means the more confident you have. There is also 11 point (0-10) scale that higher the score means the more confident you are in caring for patients.

Oncology nurses' communication skills were measured by communication ability scale.It is a 5 Liker scale(1-5),higher scores represent better communication skills.

Oncology nurses' empathy were measured by Efferson Empathy Scale. It is a 7 Liker scale(1-7),higher scores means someone have more empathy.

Oncology nurses' spiritual well-being were measured by FACIT-Sp.It is a 5 Liker scale(0-4),higher scores represent better well-being.

National Taiwan University Hospital

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Patient-perceived empathy was assessed using the Consultation and Relational Empathy (CARE) questionnaire that has been validated in cancer care. This is a self-reported ten-point questionnaire with a five-point Likert-type scale ranging from "poor" to "excellent" Likert-type scale. It has excellent psychometric properties with α = 0.92. High scores indicate a higher perception of the health care personnel empathy.

The three distinct empathic processes were also assessed with the CARE measure. 'Relationship' was assessed with items 1-3, 'emotional process' with items 4-6, and 'cognitive process' with items 7-10.

In line with the recent literature, we considered differentiating the study population into two groups: those with a high perceived empathy (maximum CARE score) and those without.

The aim of project EMPACOL will be to investigate, while taking into consideration the clinical factors known and well described in the literature, among the non-clinical factors, in particular, patient-healthcare personnel (HCP) relationship, a link between HCP's empathy perceived by the patient, and the results of the curative treatment of non-metastatic colorectal cancer, throughout the patient's care.

EMPACOL will be a multicenter prospective longitudinal study. Over a 2-year period, in two French areas covered by a cancer register, 8 centers will include patients with non-metastatic CRC, uncomplicated at diagnosis Based on the curative treatment strategy, patients will be divided into three groups: group 1 (surgery alone), group 2 (surgery and adjuvant chemotherapy), group 3 (neo-adjuvant therapy, surgery and adjuvant chemotherapy).

The relationship between HCP's empathy, perceived by the patient, after 2 years of inclusion, and the quality of life (QoL) at one year after the end of treatment will be investigated. QoL will be investigated using the QLQ C-30 questionnaire. Finally, a link between PHC perception and oncological outcomes will be sought.

Role of Empathy in Curative Treatment Outcomes of Non-metastatic Colorectal Cancer.

Role of Empathy in the Outcome of Curative Treatment of Non-metastatic Colorectal Cancer. Prospective Multicenter Longitudinal Study in Two Departments Covered by the Calvados Cancer Registry.

Based on the curative treatment strategy, patients with non-metastatic CRC will be divided into three groups: group 1 (surgery alone), group 2 (surgery and adjuvant chemotherapy), group 3 (neo-adjuvant therapy, surgery and adjuvant chemotherapy).

The relationship between patient-perceived HCP empathy after 2 years of inclusion and 5-year survival will be studied.

Quality of life will be studied using the QLQ C-30 questionnaire.

University Hospital, Caen

Breast Diseases

Skin Diseases

The e-consult tool is a digital application developed and designed by the Center François Baclesse, This tool is a consultation support to explain the surgical management of the patient.

A numeric application used as a support in consultation to explain the surgical management of the patient.

e-consult application (tool)

Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.

The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.

The average obtained in the CARE questionnaire by patients (score \[10-50\])

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Empathy and Standard Diagnostic Procedures in an Outpatient Breast Clinic Might Not be Enough	NCT02796612	Anxiety	no intervention delivery of a t... patient care by...	18 Years -	University Hospital, Basel, Switzerland
The Effects of Multi-Psycho-Oncology Care Courses	NCT05776680	Cancer Psychological Oncology Empathy	Psychological s...	20 Years -	National Taiwan University Hospital
Role of Empathy in Curative Treatment Outcomes of Non-metastatic Colorectal Cancer.	NCT05447611	Non-metastatic ... Empathy Morbidity Morality Quality of Life		18 Years - 80 Years	University Hospital, Caen
The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.	NCT04688762	Breast Cancer Surgery	e-consult appli...	18 Years -	Centre Francois Baclesse
The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.	NCT04688762	Breast Cancer Surgery	e-consult appli...	18 Years -	Centre Francois Baclesse
The Effects of Multi-Psycho-Oncology Care Courses	NCT05776680	Cancer Psychological Oncology Empathy	Psychological s...	20 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for empathy

Every month we try and update this database with for empathy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for empathy

Every month we try and update this database with for empathy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for empathy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.